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| Product NDC Code | 44577-623 | ||||
|---|---|---|---|---|---|
| Drug Name | Kera hc |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 106258, 1314932 |
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| Application Number | M017 | ||||
| Labeler Name | Clinical Therapeutic Solutions | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Hydrocortisone-USP 1.00%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions: For itching of skin irritation, inflammation and rashes: Apply to affected area not more than 3 to 4 times daily. Not for use by children under 2 years of age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, c13-14 Isoparaffin, Ethylhexylglycerin, Glycerin, Heilianthus Annuus (Sunflower) Seed Oil, Laureth-7, Phenoxyethanol, Polacrylamide, Polysorbate-20, Tocopheryl Acetate (Vitamin E), Urea-USP.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses: Temporarily relieves itching associated with minor skin irritations, inflammations and rashes due to: Excessively Dry Skin, Eczema, Insect Bites, Poison Ivy, Oak or Sumac, Soaps, Detergents, Cosmetics, Jewelery, Seborrheic Dermatitis, Psoriasis Other uses of this product should only be under the advice and supervisor of a doctor
Purpose
Information about the drug product’s indications for use.Purpose Anti-Itch
Spl product data elements
Usually a list of ingredients in a drug product.KERA HC HYDROCORTISONE ALOE VERA LEAF WATER ALKYL (C12-15) BENZOATE C13-14 ISOPARAFFIN ETHYLHEXYLGLYCERIN GLYCERIN SUNFLOWER OIL LAURETH-7 PHENOXYETHANOL POLYSORBATE 20 .ALPHA.-TOCOPHEROL UREA HYDROCORTISONE HYDROCORTISONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.KERA HC Cream Hydrocortisone 1% 2oz/56g (44577-623-02) KERAHC
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.KERA HC Cream Hydrocortisone 1%
Distributed By: Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719 www.CTSRX.com
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, contact physician or poison control center immediately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if: Condition worsens or symptoms persist for more than 7 days, or if symptoms clear up, and then return
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product: Avoid contact with eyes Do not use more than directed unless told to do so by a doctor
Storage and handling
Information about safe storage and handling of the drug product.Store at room temperature (20-25 degrees C) (68-77 degrees F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API